Lab Medicine in Space Free

Introduction

As humanity continues to push towards interplanetary travel and beyond, short- and long-term adaptation of the human body to extreme environmental conditions in space remains a fundamental concern. An astronaut is subjected to physically and mentally enduring situations like microgravity, extreme heat or cold, radiation, isolation, and other unforeseen technical challenges. To manage the physiological impact of these situations, the use of real-time diagnostic laboratory medicine will be necessary for the health of the astronaut. With advancing technology, the recent implementation of point-of-care testing (POCT) on the International Space Station (ISS) provides a means to reduce the need to freeze and send specimens back to earth for analysis. However, the quality of these lab tests in a microgravity environment continues to be investigated. Similar to traditional laboratory medicine, there are laboratory analysis concerns during space travel such as pre-analytical errors, competency, interface issues, specimen type differences, reference intervals, and consumable storage. As the frequency and duration of human spaceflight increases, research in these areas of laboratory testing will be key for space travel and astronaut health. For this Q&A, we invited a diverse group of experts to explore the current and desired future state of laboratory medicine in space as well as innovations that will expand our current horizon within this area of interest.

Briefly describe your role and experience in space and lab medicine.

Kathleen McMonigal: I am an anatomical and clinical pathologist in the Space Medicine division at the NASA Johnson Space Center (JSC) where I direct the JSC Clinical Laboratory. The College of American Pathology (CAP) accredited laboratory is responsible for all clinical laboratory testing at the Center, which includes the Flight Medicine Clinic and the Occupational Medicine Clinic. The Flight Medicine Clinic provides comprehensive medical and behavioral healthcare for active astronauts as well as conducting annual visits for former astronauts, as part of the lifetime occupational surveillance of astronaut health (LSAH). My laboratory provides comprehensive laboratory testing for astronaut selection and recertification. As part of the Flight Medicine Clinic, the JSC Clinical Laboratory continues to track astronauts once they leave the astronaut corps with periodic examinations for the rest of their lives. A continuous laboratory record of all laboratory encounters has been maintained since the Gemini space program in the 1960s.

As a NASA pathologist, I participate in expert panel reviews of laboratory test profiles and other ancillary testing for astronauts. Laboratory testing is used to identify diseases, or predisposition for diseases, which might compromise individual health or mission safety. The goal is to assure the health, safety, mission success, and career longevity of astronauts.

Guy Trudel: I am a physical medicine and rehabilitation specialist working at the Ottawa Hospital Rehabilitation Centre, Canada. Our group is carrying out clinical and laboratory-based research on the deleterious effects of prolonged immobility. The complications and the rehabilitation of astronauts returning from space are very similar to patients who have been bedridden after long hospital stays. In fact, an Earth-based analogue to space is prolonged bed rest in the anti-orthostatic position. Research findings may apply to both populations. We have researched the effects of prolonged space exposure on red blood cell (RBC) number modulation. This included collection of blood, preparation of serum, and collection of exhaled air samples on ISS. These were prepared and stowed on the ISS in specific conditions, and then later returned to Earth for analysis in a specialized laboratory. Samples could be divided among several researchers to maximize research use, aliquoted for multiple facilities, then transported to their final location and processed for final measurements.

Brian Crucian: I am an American Society for Clinical Pathology-certified clinical laboratorian who completed a PhD in research immunology. At NASA, I lead the Immunology and Virology Laboratory, and conduct studies to determine clinical risks for astronauts during spaceflight. The studies are designed to focus on diagnostic relevance as opposed to mechanistic research. Our laboratory also leads efforts to develop biomedical countermeasures and prototyping or validating potential microgravity-compatible laboratory instruments. Clinical laboratory monitoring will be necessary on the Moon or Mars!

Afshin Beheshti: I am a bioinformatician and principal investigator working with Kellogg Brown & Root (KBR) at the NASA Ames Research Center. Currently I have several grants from NASA and the Department of Defense that are funding my research on various subjects related to space biology. Specifically with space and lab medicine, I have been actively working on various NASA and space biology related projects since 2006, which has involved simulated space radiation experiments at the NASA Space Radiation Laboratory (NSRL) at the Brookhaven National Laboratory (BNL). This has involved procurement of tissue samples from mice flown to the ISS, and data generated from various missions involving astronauts. In addition, I have worked for NASA’s GeneLab platform, which is an open science data repository and tool that contains the majority of the omics data associated with spaceflight. I’m also the lead of GeneLab’s Multi-omics Analysis Working Group (AWG), which has 250+ members. The AWG brings together scientists from all around the world to work as an open science collaborative group on various space biology topics.

Fathi Karouia: For more than 20 years, I have worked on space life sciences research in both academic and governmental settings. My research encompasses several areas of translational research associated with space biology, human spaceflight, and space technologies. Additionally, I am involved in the development of portable, microfluidics, and automated high-throughput technologies for in situ processing and analysis of human and other biological samples in space. I also possess extensive experience with in-flight projects. For instance, I have led over 30 flight projects successfully operated on the ISS as the Non-Rodent Portfolio Lead Scientist or as a project scientist under the NASA Space Biology Program. I have supervised the design, development, and implementation of 18 successful investigations involving human and model organism-based research aboard the ISS.

What are the major challenges of laboratory medicine in space?

Guy Trudel: From the perspective of an investigator, the adaptation of earthly methods to space requires thoughtful and inventive methods. Aliquoting, filtering, or adding solutions either introduced the risk of free-floating biological hazard aboard the ISS or required an inordinate amount of astronaut time to safely conduct. We collected serum in double-gel tubes; after centrifugation, they were frozen to −80°C. We retrieved them after landing, thawed and aliquoted to measure serum analytes including leukocyte transcriptomics. Given the extreme conditions for phlebotomy and blood processing, sample degradation can happen including ex vivo sample hemolysis. One solution around the measure of blood markers was to measure an erythrocyte metabolite, namely carbon monoxide (CO) in exhaled air as a non-blood marker of hemolysis. Sturdy pre-vacuumed metal canisters (stainless steel canisters designed to hold vacuum available in a range of volumes) to collect air samples ensured resistance to re-entry conditions of gravitational force, vibration, and temperature. Testing on Earth demonstrated signal stability for extended durations corresponding to the requirements of the space payload.

Brian Crucian: Efforts are underway to determine what biomarkers should be monitored in astronauts during spaceflight. For space vehicles, “operational constraints” include volume, weight, power, reagent stability, waste generation/disposal, and microfluidics in microgravity. There are multiple international efforts underway to develop miniaturized, low power, microgravity-compatible laboratory instruments. I would anticipate the needs will include cellular analyses, soluble inflammatory markers, and other relevant biomarkers such as latent herpesvirus reactivation—an excellent biomarker for clinically relevant immune dysfunction.

Kathleen McMonigal: Some of the greatest challenges associated with supporting astronauts on the ISS are the logistics of supplying everything required for living there. All supplies must be transported to the ISS by uncrewed cargo vehicles, which is done several times per year. These payloads are estimated to cost $10 000 per pound. However, supplies essential to astronaut well-being and the success of the mission will take priority over the other payloads. In addition, despite the description of the ISS as the size of a 5-bedroom house, with the capability to use all surfaces for storage, the actual usable volume and storage space are constrained. The more compact the device, the easier it is to arrange for a spot in the cargo vehicle and on the ISS when the device arrives.

Any piece of hardware going to space must undergo testing for ruggedness and be able to withstand the vibrations of the launch. All hardware must be tested for chemical off-gassing and trace contaminants, to minimize the strain on the ISS air handlers and trace contaminant control systems. Many laboratory analyzers cannot sustain the rigors of this ruggedness testing and therefore are not suitable for spaceflight.

The behavior of fluids in microgravity complicates laboratory testing. Liquid reagent vials or syringes will show even-dispersal of air and liquid, with disappearance of the air–fluid interface and resultant formation of bubbles. This challenges the functionality of the instrument and may result in damage to sensitive equipment. Liquid droplets can float freely in the air without a container, which can potentially create a hazard for crew and equipment. The use of microfluidics in laboratory testing is being explored.

The ISS has no refrigerated storage space for reagents, controls, or calibrators. Thus, room temperature shelf-life-stable reagents are required. There is an experiment storage freezer, known as the Minus Eighty-degree Laboratory Freezer for ISS (MELFI), which holds research blood and urine specimens obtained from crew members on orbit. NASA uses SpaceX Dragon cargo vehicles to transport equipment and frozen research samples home from the ISS. The samples obtained are for research use only and no samples are obtained for clinical use. All supply vehicles, other than the Dragon, burn up on re-entry, limiting cargo that can be returned to Earth.

Due to challenges associated with deploying clinical instrumentation to space, medical capabilities and in-flight diagnostics are constrained. The current laboratory diagnostic capabilities on the ISS are limited to blood collection supplies, a point-of-care i-STAT analyzer, urinalysis strips, and a centrifuge. i-STAT replacement cartridges are sent on cargo vehicles several times a year, while i-STAT software updates are uploaded as needed. Laboratory testing is limited to clinically indicated evaluations. Other medical equipment on the ISS includes a portable ultrasound, an automated external defibrillator, and ophthalmologic hardware such as a fundoscope and optic coherence tomography.

There have been various technology demonstrations on the ISS to evaluate new hardware capabilities, such as a white blood cell (WBC) analyzer with differential, but the analyzers showed limited utility, which did not justify keeping them aboard the ISS.

Fathi Karouia: Conducting science or monitoring the health of astronauts on board the ISS comes with several significant challenges beyond the microgravity environment. These challenges include limited access to and from space, the need for cold storage, scheduling crew time, and access to analytical instruments. While there are some instruments on board, such as microscopes, spectrophotometer plate readers, and PCR-based devices, most hardware devoted to space life sciences are incubators. However, many of the instruments on board the ISS arrived several years after their commercial availability on Earth, leading to a delay in space research progress, which can be referred to as “the lag phase of space research.” Although some instruments required modifications to operate in space, many did not, which has resulted in the paradox of space life sciences where the ISS is primarily used to expose biological systems, including humans, to the environment, and most analysis is conducted on ground. Additionally, performing experiments in space is a challenging task, and despite the best efforts of the crew, issues and mistakes associated with hardware, sample integrity, contamination, operation procedures, and handling fluids are inevitable.

Afshin Beheshti: The main issues for research in space are sample accessibility, doing experiments, and the number of biological replicates that can be utilized. In general, experiments conducted in space are expensive and a limited number of investigators are awarded grants to fund them. This limits the research and investigative efforts necessary to elucidate space biology. In addition, due to space constraints on the ISS and limited crew time, there are reduced numbers of replicates. Also, due to the lack of gravity, this also will reduce the types of experiments that would easily be performed on Earth. For example, cell culture experiments, which might typically take 10 minutes to do on Earth, can take anywhere from 30 minutes to an hour in the unique space environment. Lastly, access to human data in space is limited due to Institutional Review Board (IRB) issues related to identifiable data, the low number of astronauts, and limited access to astronauts.

Why are lab medicine specialists critical to successful space missions?

Fathi Karouia: It is highly probable that in the near future, lab medicine specialists or scientists will be dispatched to conduct research in low Earth orbit (LEO). To facilitate this endeavor, NASA’s biological and physical sciences division is conceptualizing an initiative called Commercially Enabled Rapid Space Science (CERISS), which will transport highly specialized scientists to conduct research that even the most extensively trained astronauts may find arduous to perform. Furthermore, one of the forthcoming commercial space stations, Orbital Reef, is proposing a similar initiative in which specialized astronauts will receive training in scientific research and manufacturing. Hence, there will be a need for proficient and multidisciplinary space lab medicine experts to conduct investigations and monitor the health of astronauts.

Afshin Beheshti: Pathologists and lab medicine expertise will be important for space biology experiments. They will be able to help assess potential pathology and health risks that might occur during spaceflight. For research experiments, when getting blood samples or biopsies from astronauts, pathologists will help identify the changes observed during spaceflight and offer their interpretive expertise.

Guy Trudel: Astronauts undergo multisystem transformations, many driven by a microgravity-induced fluid shift which result in hemoconcentration, decreased blood volume, and interstitial fluid loss, and cardiovascular, neurological, and ophthalmologic changes, while others are related to the inactivity and microgravity environment (bone resorption, muscle atrophy, etc.). Expertise in lab medicine is critical to integrate the various changes happening to every organ into a proper interpretation of the changes.

Brian Crucian: Having a crew member on board a deep space mission with lab medicine training would have obvious benefits, but it is unlikely to be a mission requirement. Therefore, flight laboratory instruments should be robust and simple to use, such that a non-lab medicine specialist crew member can, on minimal training, collect a specimen, perform the evaluation, and relay data back to Earth for interpretation by a pathologist, hematologist, or flight surgeon. Such medical experts are critical to mission success but can serve Earth-bound via telemedicine.

Kathleen McMonigal: Space medicine includes the care of healthy individuals living in extreme environments. The role of NASA flight surgeons is to monitor the health of astronauts and specifically to support all crews prior to, during, and after spaceflight. One key aspect of astronaut medical care is pre-flight medical, laboratory, and behavioral screening. Because medical capabilities on the ISS are limited, medical conditions that could interfere with a successful mission are identified and resolved. Generally, laboratory profiles are within the clinical normal ranges for a 6-month mission.

In-flight medical care is provided by designated crew surgeons and behavioral health teams for each mission. These crew surgeons oversee the health of their crew via telemedicine, using private medical conferences. Many spaceflight missions do not have a physician-astronaut crew member. A crew surgeon or another physician with special expertise may guide a non-physician astronaut onboard the ISS through a technical procedure for medical evaluation.

Because of training in disease pathophysiology, a pathologist is knowledgeable in a spectrum of disease manifestations. A laboratory medicine specialist also has a keen sense of what is “normal” for a population because of the breadth of laboratory data routinely reviewed. When monitoring very healthy astronauts who train and live in extreme environments, the pathologist can promptly initiate follow-up when a slight deviation from normal or from an individual’s prior laboratory results is seen.

What quality control/quality assurance (QC/QA) processes have been effective for preserving the integrity of data produced by spaceflight lab tests?

Brian Crucian: This is an excellent question; however, most technologies are not mature to have proceeded to this level of process development. The focus is still on “inventing,” either by a space agency or a commercial company, the miniaturized instruments mentioned throughout this article. Anticipating the need for flight-certified controls and standards, the constraints for deep space will be stability, storage conditions, and cellular integrity. A recent ISS evaluation of a small commercial hematology analyzer involved flying standard laboratory cellular commercial controls and found that over the period from launch to the flight evaluation, some degradation had occurred. This problem magnifies exponentially for deep space missions. It is highly likely that QC/QA simply cannot be performed in deep space to the rigor of a terrestrial laboratory, and trade-offs will be needed to achieve the basic monitoring required.

Kathleen McMonigal: While there is no in-flight data, all pre- and post-flight laboratory data is preserved in a longitudinal database that is part of the laboratory information system. All CAP accreditation practices are followed.

The JSC Clinical Laboratory has established the NASA Biological Specimen Repository for future spaceflight research when the ISS is no longer operating. After the in-flight repository samples, serum, plasma, and urine, are returned from the ISS, they are thawed once and tested prior to long-term storage to provide a baseline from which to assess the quality of the samples once thawed and distributed. Blood is tested for total protein, chloride, calcium, and blood urea nitrogen. Urine is tested for total volume, calcium, creatinine, and phosphorus. Aliquots (500 µL) are placed in tubes for storage at −80°C, until the repository is opened. At that time, the specimens will be analyzed for determination of specimen integrity prior to distribution of the samples. Other QA measures will be followed as specified in the CAP Biorepository program.

Fathi Karouia: The safety of the crew and the integrity of the ISS are of utmost importance. Consequently, there are numerous regulations in place regarding chemicals, toxicity levels, samples, biosafety levels (BSL), and other factors on board the space station. Despite these restrictions, it is still possible to utilize certain chemicals to safeguard the integrity of samples. For instance, formaldehyde is frequently used to preserve samples for imaging, while DNA/RNA stabilization reagents are used to maintain samples for molecular-based assays. Nonetheless, freezing continues to be one of the most effective methods for sample preservation. The station is equipped with several active (+4°C to −160°C) and passive (+4°C to −32°C) cold storage facilities. Moreover, a rapid freeze container is now available and can be positioned inside the glove box which is essentially a sealed container specifically designed to handle materials in a different environment. This container allows for the immediate freezing of samples to ensure their optimal preservation when they are retrieved from the hardware.

Afshin Beheshti: The key for QC/QA integrity is to have all samples processed by the same method and it helps to have the same team processing the samples. For example, for rodent research missions at NASA, there is a dedicated team of skilled scientists that would handle the majority of the missions. This would assure that the same procedures will be utilized every time. In addition, for post-processing tissues, one core facility will process samples via standard operating procedures. This example can be seen with NASA’s GeneLab team, which has produced high quality and consistent data that they have made available to the community on their platform. They have processed tissues for RNA sequencing consistently and the data produced can reliably be compared from different missions.

Guy Trudel: Various strategies can be used to validate data. One ingenious approach has been to uncouple the experimental blood draws to the mission time and couple it to the timing of vessel egress from the ISS to Earth. This allowed the processing of fresh blood and enabled the production of data not otherwise available. This approach benefitted from synchronous blood draws on earthly controls where the samples were kept under similar temperature conditions as the space samples.

In what ways can laboratory technology evolve to support upcoming space missions?

Kathleen McMonigal: As missions change from ground-based to deep space missions, there will be a need for a single compact device that is easy to use and can be deployed in a small, confined space. Ideally, this device could be used for multiple sample types, including breath and saliva, multiple analytes, and could perform on-orbit rapid analysis. Mobile device technology will be important, such as medical accessories for smart phones, cameras, video recorders, and sensor innovations to measure vital signs, and require minimal training with intuitive user interfaces.

Recently, there were 2 major competitions for small portable devices with medical sensors that could identify several important health conditions. The $10 million Qualcomm Tricorder XPRIZEs were awarded in 2017 while the $2.25 million Nokia Sensing XCHALLENGE winner was announced in 2014. Each of the winners and runners-up developed innovative solutions for diagnosing multiple medical conditions, with the FDA providing regulatory input to prepare for potential FDA reviews. One of the winners has utilized microfluidics technology for handling fluids during space travel.

Afshin Beheshti: Increased automation in both space and on Earth will allow for efficient and consistent production of samples and data. Also, developing sequencing capability in space in a small and automated matter will help push science forward. Currently, there are capabilities for low read sequencing that has been proven useful. Expanding on this will allow for better data to be produced at a higher rate. For post-processing on Earth, expanding omics capabilities to more advanced technology will further expand the understanding and data. For example, spatial RNA sequencing and proteomics will be a great next step.

Fathi Karouia: From an analytical perspective, the ISS is not the most advanced laboratory available. However, the recent introduction of the MinION by Oxford Nanopore Technologies in 2016 represented a significant step forward. While it is used primarily for environmental monitoring and detecting microbial contamination, using the MinION in microgravity remains a challenge, as it requires complex procedures that may be difficult for astronauts to perform. In order to ensure the long-term success of space exploration missions, it will be critical to improve our ability to analyze and process samples from a variety of sources. This will require the use of multi-omics platforms, which will need to be hybrid-based, plug-and-play technologies that can be adapted to space conditions. Additionally, a fully automated, miniaturized, and microfluidics-based system for processing and analyzing samples would be highly beneficial. By implementing these technologies, we can make significant progress in understanding the health risks associated with space travel, and make discoveries that will benefit both space exploration and life on Earth.

Brian Crucian: Whether spearheaded by space agency funding, or the commercial sector striving for robust point-of-care (POC) devices, the needed advancements are occurring today. Microfluidics, unique biosensors, diode lasers, magnetic separations, and myriad of other technologies are emerging that are likely to be sufficient to enable small flight analyzer development. That said, some technologies are taking time to overcome technical challenges associated with development. Currently, 2 novel technologies are being evaluated at Palmer Station, Antarctica, for their ability to monitor latent virus DNA in saliva. If successful, these technologies should undergo further evaluation.

Guy Trudel: Most laboratory measures currently cannot be completed by a POC laboratory set up in spacecrafts. However, upcoming space missions would benefit from a paradigm shift: from bringing the sample to the laboratory to bringing the laboratory to the sample or POC approach. This approach appears feasible, but its development is facing unique challenges. Issues include availability, storage and conservation of reagents, versatility of the systems, function in a microgravity environment, user-friendly interface, calibration, precision, volume, weight, and energy consumption. Microfluidics, exploring the closed-loop treatment of samples for a limited number of measures must resolve the above challenges before being recommended for onboard space laboratories.

What are your opinions on promoting the applications lab medicine in space travel?

Guy Trudel: Space lab medicine should become mainstream as it would benefit the trainee curriculum in multiple aspects. It will enable physiological and pathophysiological understanding of the effects of human exposure to this specific extreme environment where every system is affected. Soon, space medicine will no longer be limited to selected countries’ space agencies. Space tourism will expand the effects of exposure to space to populations other than trained professional astronauts. There will be a need for pre-flight screening for selected conditions most affected by space. Medical complications in space and after returning to earth will require expertise in the interpretation of test results.

Fathi Karouia: As space access becomes more accessible to a wider range of individuals, it will become increasingly important to have skilled scientists who can perform experiments and research in LEO. However, until that time, it will be essential to promote and include space life science in educational curricula. Encouraging more students and early-career scientists to become involved in space research is crucial for addressing the potential risks associated with long-duration space travel. The study of how life adapts to different space environments, such as those found on the Moon and Mars, will be a critical pursuit in sustaining space exploration. As a result, I firmly believe that the emphasis should be on generating interest in space research, rather than solely developing specific skills associated with space laboratory medicine.

Brian Crucian: A pattern of immune dysregulation, and some level of adverse medical events, occur during orbital flights to ISS. During deep space missions to the lunar Gateway station, the lunar surface, or to Mars, all the mission stressors will increase. In the event of an emergency, our ability to resupply, rapidly return, and generally care for the crew will be reduced. Therefore, deep space laboratory diagnostic capability is of paramount importance.

Kathleen McMonigal: As space travel increases, physicians will be interested in learning about the physiological and sometimes pathologic changes occurring in the microgravity environment. Such topics can be addressed in special sessions at conferences of all medical specialties.

Afshin Beheshti: I’m all for expanding the capabilities and expertise for space lab medicine. This will be a key step to assuring catching early health risks in astronauts during and after spaceflight.

What specialized training do you anticipate that lab medicine specialists will need for the deep space missions?

Afshin Beheshti: There will be a need for real-time health monitoring and countermeasures to reduce and mitigate the damages caused by certain risks. For example, developing a real-time blood assay to monitor health risks will allow for constant monitoring of when we will need to either send the astronaut back to Earth or administer the correct countermeasure to reduce the health risk. For my work, I have been researching how a circulating factor, microRNAs (miRNAs), can indicate potential health risks related to different pathology such as cardiovascular risk or muscle wasting. I have identified a set of circulating miRNAs that increase during spaceflight and the different levels of increasing factors is related to the onset of different health risks. With this increase, one can then administer inhibitors to these miRNAs to reduce the levels back down to baseline. This will help reduce increased health risks during deep space missions.

Brian Crucian: While physician, emergency medical services, or laboratory skills are clearly of benefit, they are unlikely to be a requirement for deep space missions. Therefore, ease-of-use for deep space laboratory instrument will be important, as will general pre-mission training. Even on the ISS, there is a class of payload that does not require pre-mission training. Instead, onboard training videos are utilized. Medical devices frequently fall to this category, such as a miniaturized hematology analyzer, small flow cytometer, and small digital microscope with wright stain blood smear capabilities. All were recently evaluated by ISS crew members using this training paradigm.

Fathi Karouia: To excel in deep space missions, a space lab medicine specialist must possess not only exceptional scientific expertise, problem-solving abilities, and a strong work ethic, but also possess several key traits commonly associated with successful astronauts—often referred to as “the right stuff.” These qualities include the capacity to perform effectively in microgravity environments, the ability to perform under pressure, adeptness at multitasking, fluency in multiple languages, the aptitude for working harmoniously with teammates in a confined space, the capability to cope with loneliness and isolation while being away from loved ones, and strong communication skills.

Guy Trudel: Deep space missions add at least 2 major challenges compared to near-Earth experiments. First, the impossibility to communicate in real-time between Earth and the vessel. Real-time communication is possible for the LEO ISS, but a craft near Mars will face a multi-minute communication lag. This lag will prohibit real-time operations under Earth-based specialist guidance. Second, the inability to resupply. Remedies would include prepared manuals with instructions for procedures, and a versatile laboratory where a few basic tools could be assembled to serve multiple purposes, possibly with assistance of artificial intelligence. This laboratory’s function can span the preparation of medications or of reagents to be used across multiple functions.

Kathleen McMonigal: All space medicine specialists will require an understanding of the challenges of spaceflight missions. These include how astronauts respond to the stresses of spaceflight, focusing specifically on the cognitive and psychological effects of long durations in space and the attendant isolation, fatigue, altered light–dark cycles, and microgravity.

Today, there are several programs offering residencies in space medicine, and it is anticipated that more academic programs will be offered within the near future. With commercial spaceflight programs offering participants travel into space, the need for space medicine specialists will expand.

Nonstandard Abbreviations

ISS, International Space Station; JSC, Johnson Space Center; QA, quality assurance.

Author Contributions

All authors confirmed they have contributed to the intellectual content of this paper and have met the following 4 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; (c) final approval of the published article; and (d) agreement to be accountable for all aspects of the article thus ensuring that questions related to the accuracy or integrity of any part of the article are appropriately investigated and resolved.

Joesph Wiencek (Writing—original draft, Writing—review & editing), Saswati Das (Writing—original draft, Writing—review & editing), Beheshti Afshin (Writing—original draft-Supporting, Writing—review & editing-Supporting), Brian Crucian (Writing—original draft-Supporting, Writing—review & editing-Supporting), Fathi Karouia (Writing—original draft-Supporting, Writing—review & editing-Supporting), Guy Trudel (Writing—original draft-Supporting, Writing—review & editing-Supporting), and Kathleen McMonigal (Writing—original draft-Supporting, Writing—review & editing-Supporting)

Authors’ Disclosures or Potential Conflicts of Interest

Upon manuscript submission, all authors completed the author disclosure form. Disclosures and/or potential conflicts of interest:

Employment or Leadership

J.R. Wiencek, Clinical Chemistry, AACC, AACC Serology Task Force, IFCC’s Task Force on Ethics, and AACC’s SYCL Core Committee; S. Das, member of AACC Personalized Medicine Division (unpaid) and Member of Women in Global Health India (unpaid).

Consultant or Advisory Role

J.R. Wiencek has performed consultant work for the Cystic Fibrosis Foundation.

Stock Ownership

None declared.

Honoraria

J.R. Wiencek has received honorarium from AACC and Cardinal Health.

Research Funding

S. Das is recipient of 1.6 million INR as research grant from Department of Science and Technology, Government of India. B.E. Crucian, NASA Johnson Space Center and International Partner Space Agencies. G. Trudel’s work is supported by the Canadian Space Agency.

Expert Testimony

None declared.

Patents

J.R. Wiencek has 2 provisional patents related to SARS-CoV-2 testing (U.S. Provisional Patent Application Serial No. 63/015,215 and International Patent Application Serial No. PCT/US2021/029187).

Other Remuneration

J.R. Wiencek has received travel support to attend AACC, ASCP, and IFCC meetings.